Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-27 @ 9:36 AM
Study NCT ID:
NCT00127959
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2005-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'C098320', 'term': 'efavirenz'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-23', 'studyFirstSubmitDate': '2005-08-08', 'studyFirstSubmitQcDate': '2005-08-08', 'lastUpdatePostDateStruct': {'date': '2007-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with undetectable HBV DNA in serum'}, {'measure': 'Rate of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) seroconversion'}, {'measure': 'Rate of emergence of lamivudine (LAM)-resistant HBV genotypes'}, {'measure': 'Suppression of plasma HIV-RNA (< 50 copies/ml)'}, {'measure': 'Changes in CD4+ /CD8+ cell counts'}, {'measure': 'Presence of covalently closed circle DNA (cccDNA) on liver biopsy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-1', 'HBV', 'treatment', 'tenofovir', 'emtricitabine', 'Treatment Naive', 'HIV-1 infection', 'Hepatitis B virus infection'], 'conditions': ['HIV Infections', 'Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).\n\nPlus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)', 'detailedDescription': 'This is a randomized multicentre trial of FTC vs TDF/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).\n\nPlus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)\n\nPrimary Objectives:\n\n* To compare the proportion of subjects with HBV DNA levels below the limit of detection (\\<400 copies/ml) by week 48 in each treatment group\n\nSecondary Objectives:\n\n* To evaluate the emergence of HBV resistance at 48 weeks\n* To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group\n* To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12, 24 and 48 during the study\n* To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT\\>5x ULN)\n* To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts over 48 weeks\n* To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA\n\nEnrollment:\n\n* 24 patients in Clinical trial A (of whom 16 enter substudy A1).\n\nClinical Trial A:\n\n* Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viraemia and are willing to start antiretroviral therapy.\n\nInclusion Criteria:\n\n* Written informed consent\n* Documented HIV infection\n* Age 18 - 70 years\n* HBV DNA \\> 106 copies/ml\n\nRandomization:\n\n* Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)\n* Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* Documented HIV infection\n* Age 18 - 70 years\n* HBV DNA \\> 10E6 copies/ml\n* ALT \\< 10 x ULN (upper limit of normal)\n* Creatinine \\<= 2.0mg/dl\n* Platelet count \\>= 50,000/mm3\n* HIV-1 therapy naive\n* No prior exposure to anti-HBV agents\n\nExclusion Criteria:\n\n* Hepatitis C viral RNA (CV-RNA) positive or Anti-hepatitis A virus immunoglobulin M (HAV IgM) positive\n* Acute hepatitis (serum ALT \\> 1000 U/L)\n* Prior LAM, TDF, or adefovir dipivoxil (ADV) therapy\n* Active opportunistic infection\n* Pregnancy or lactation\n* Other chronic liver disease\n* Concurrent malignancy requiring cytotoxic chemotherapy\n* Decompensated or Child's C cirrhosis\n* Alfa-fetoprotein (AFP) \\> 3X ULN (unless negative computed tomography \\[CT\\] scan or magnetic resonance imaging \\[MRI\\] within 3 months of entry date)"}, 'identificationModule': {'nctId': 'NCT00127959', 'briefTitle': 'Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection', 'organization': {'class': 'OTHER', 'fullName': 'International Antiviral Therapy Evaluation Center'}, 'officialTitle': 'Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV co-Infection', 'orgStudyIdInfo': {'id': 'IAT-0038-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tenofovir', 'type': 'DRUG'}, {'name': 'emtricitabine', 'type': 'DRUG'}, {'name': 'zidovudine', 'type': 'DRUG'}, {'name': 'efavirenz', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Joep M.A. Lange, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'Kiat Ruxrungtham, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HIVNAT Bangkok'}, {'name': 'Jan Prins, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Antiviral Therapy Evaluation Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}]}}}